CryoLife ($CRY) achieved premarket approval for a new disposable device that aids a transmyocardial revascularization procedure.
The PMA designation covers the company's Sologrip minimally invasive laser fiber-optic delivery system. It's a single-use disposable handset. Company Chairman, President and CEO Steven Anderson said in a statement that he hopes the updated tool will help boost use of the company's Cardiogenesis transmyocardial revascularization (TMR) system as a result.
"We look forward to continuing our efforts to increase adoption of this important treatment option for patients with angina," Anderson said in a statement.
TMR procedures treat angina by using a targeted laser tool on the heart muscle to stimulate the creation of new blood vessels, CryoLife explains. CryoLife acquired the TMR system when it bought Cardiogenesis for $22 million in early 2011. CryoLife estimated the TMR market could swell to $700 million in the U.S. alone over time.
CryoLife has advanced other projects in recent weeks; the company in June won the FDA's approval to begin a U.S. trial for its PerClot bleeding-control device, with an eye toward FDA approval in 2013.
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